Actavis plc has launched its generic version of AstraZeneca’s Pulmicort Respules (budesonide inhalation suspension) 0.25 and 0.5 mg vials following a ruling from the United States District Court for the District of New Jersey that United States Patent No. 7,524,834 is invalid, and AstraZeneca’s request for a permanent injunction is denied.

Actavis’ abbreviated new drug application for its generic version of Pulmicort Respules received final approval from the US Food and Drug Administration in August 2012. The drug is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended June 30, 2014 total U. brand and generic sales of Pulmicort Respules were approximately $1.1 billion, according to information from Actavis  

In a statement, Paul Hudson, president, AstraZeneca US and executive vice president, North America said: “AstraZeneca strongly disagrees with the Court's decision. AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal.”

The decision is limited to the United States and has no impact on the validity of patents related to Pulmicort Respules in other countries. The 834 patent was set to expire in 2018, with pediatric exclusivity extending into 2019.

AstraZeneca had filed patent infringement lawsuits against Apotex Inc., Apotex Corp., Watson Laboratories (now Actavis), Breath Limited, and Sandoz Inc., for infringement of US patents directed to methods of use and formulation and form of active ingredient (budesonide) for Pulmicort Respules. In April 2013, the US District Court for the District of New Jersey ruled that AstraZeneca's US Patent No. 6,598,603 (“the ‘603 patent”) was invalid. The Court further ruled that the generic defendants involved in the litigation do not infringe AstraZeneca's second patent, US Patent No. 7,524,834 (“the ‘834 patent”). In October 2013, AstraZeneca announced that the United States Court of Appeals for the Federal Circuit had reversed and remanded for further proceedings the US District Court decision that generic defendants involved in the litigation do not infringe the ‘834 Patent. The Court of Appeals upheld, however, the trial court's decision as to the ‘603 Patent. At the remand, AstraZeneca contended that the defendants' generic budesonide inhalation suspension products and their use will infringe the claims of the ‘834 Patent. The defendants denied that they will infringe and asserted that the ‘834 Patent is invalid.

Under agreement with AstraZeneca, Teva has a generic Pulmicort Respules product in the market.

Source: Actavis and AstraZeneca